Endovascular device with a tissue piercing distal probe and associated methods

ABSTRACT

Devices, systems and methods for treating diseases and disorders effecting the cardiovascular system of the human body are disclosed. An exemplary blood vessel in accordance with this disclosure comprises a shaft, tip member fixed to the shaft, and a probe extending beyond a distal surface of the tip member. In some useful embodiments, the tip member is relatively atraumatic and the probe is shaped so as to be more likely to produce trauma than the tip member.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of application Ser. No. 12/320,792, filedFeb. 4, 2009 now U.S. Pat. No. 8,202,246, which claims the benefit ofU.S. Provisional Application No. 61/063,756, filed Feb. 5, 2008. ThisApplication claims the right to priority based on ProvisionalApplication No. 61/104,868, filed Oct. 13, 2008. The contents of theabove-noted applications are expressly incorporated herein by referencein their entirety.

FIELD OF THE INVENTION

The inventions described herein relate to devices and associated methodsfor the treatment of chronic total occlusions. More particularly, theinventions described herein relate to devices and methods for crossingchronic total occlusions and establishing a pathway blood flow past thechronic total occlusions.

BACKGROUND OF THE INVENTION

Due to age, high cholesterol and other contributing factors, a largepercentage of the population has arterial atherosclerosis that totallyoccludes portions of the patient's vasculature and presents significantrisks to patient health. For example, in the case of a total occlusionof a coronary artery, the result may be painful angina, loss of cardiactissue or patient death. In another example, complete occlusion of thefemoral and/or popliteal arteries in the leg may result in limbthreatening ischemia and limb amputation.

Commonly known endovascular devices and techniques are eitherinefficient (time consuming procedure), have a high risk of perforatinga vessel (poor safety) or fail to cross the occlusion (poor efficacy).Physicians currently have difficulty visualizing the native vessellumen, can not accurately direct endovascular devices toward thevisualized lumen, or fail to advance devices through the lesion. Bypasssurgery is often the preferred treatment for patients with chronic totalocclusions, but less invasive techniques would be preferred.

BRIEF SUMMARY

Devices, systems and methods for treating diseases and disorderseffecting the cardiovascular system of the human body are disclosed. Anexemplary blood vessel in accordance with this disclosure comprises ashaft, tip member fixed to the shaft, and a probe extending beyond adistal surface of the tip member. In some useful embodiments, the tipmember is relatively atraumatic and the probe is shaped so as to be morelikely to produce trauma than the tip member.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a somewhat stylized representation of a human heart. The heartincludes a plurality of coronary arteries, all of which are susceptibleto occlusion.

FIG. 2 is an enlarged view further illustrating a portion of the heartshown in the previous figure. In FIG. 2, a total occlusion is shownwithin a coronary artery.

FIG. 3 is a perspective view of a blood vessel (e.g., a coronaryartery). In FIG. 3, the wall of the blood vessel is shown having threelayers (the intima, the media, and the adventitia).

FIG. 4 is a lateral cross-sectional view of the artery shown in theprevious figure. In FIG. 4, an orienting device is shown disposedbetween the adventitia and the intima of the artery.

FIG. 5 is a longitudinal cross-sectional view of an artery having anocclusion blocking the true lumen.

FIG. 6 is an additional cross-sectional view of the artery shown in theprevious figure. In the embodiment of FIG. 6, a crossing device has beenadvanced over a guidewire so that a distal portion of crossing device isdisposed in proximal segment of the true lumen.

FIG. 7 is a plan view showing an assembly including crossing deviceshown in the previous figure.

FIG. 8 is an additional view of an artery. In the embodiment of FIG. 8,the distal end of the crossing device has been advanced in a distaldirection so that the tip of the crossing device is adjacent anocclusion that is blocking the true lumen of the artery.

FIG. 9 is an additional view of the artery and the crossing device shownin the previous figure. In the embodiment of FIG. 9, the distal end ofthe crossing device has been advanced between the intima and theadventitia of the wall of the artery.

FIG. 10 is an additional view of the artery shown in the previousfigure. In the embodiment of FIG. 10, the crossing device has beenwithdrawn and a guidewire remains in the position formerly occupied bythe crossing device.

FIG. 11 is an additional view of the artery and the guidewire shown inthe previous figure. In the embodiment of FIG. 11, an orienting device100 been advanced over the guidewire.

FIG. 12 is an additional view of the artery and the orienting deviceshown in the previous figure.

FIG. 13 is an enlarged partial cross-sectional view showing a portion ofthe orienting device shown in the previous figure. In the embodiment ofFIG. 13, a re-entry device has been advanced into the central lumen oforienting device.

FIG. 14 is an additional partial cross-sectional view showing a portionof the re-entry device and the orienting device shown in FIG. 13. Forpurposes of illustration, FIG. 14 is enlarged and simplified relative tothe items shown in FIG. 13.

FIG. 15 is an enlarged partial cross-sectional view showing a portion ofthe re-entry device and the orienting device shown in the previousfigure. In the embodiment of FIG. 15, the re-entry device has beenpositioned so that a distal portion of the re-entry device has enteredthe first aperture of the orienting device.

FIG. 16 is an enlarged partial cross-sectional view showing a portion ofa re-entry device and the intima of a blood vessel. In the embodiment ofFIG. 16, a probe of the re-entry device is contacting the intima.

FIG. 17 is an enlarged partial cross-sectional view showing a portion ofthe re-entry device shown in the previous figure. In the embodiment ofFIG. 17, the probe of the re-entry device has pierced the intima of theblood vessel. When this is the case, the probe may anchor the distal tipof the re-entry device to the intima. Additionally, the piercing of theintima with the probe may serve to weaken the intima.

FIG. 18 is an enlarged partial cross-sectional view showing a portion ofthe re-entry device shown in the previous figure. In the embodiment ofFIG. 18, the distal end of the re-entry device has been advanced throughthe intima of a blood vessel and is disposed in the true lumen of theblood vessel.

FIG. 19 is a partial cross-sectional view of the re-entry device shownin the previous figure. FIG. 19 has a different scale than the previousfigure so that more of the surrounding context is visible in FIG. 19. InFIG. 19, the distal end of the re-entry device can be seen residing inthe true lumen of the blood vessel.

FIG. 20 is an additional view of the blood vessel shown in the previousfigure. In the embodiment of FIG. 20, the orienting device has beenwithdrawn leaving the re-entry device in the position shown in FIG. 20.Devices such as balloon angioplasty catheters, atherectomy catheters,and stent delivery catheters may be advanced over the re-entry device.In this way, these devices may be used in conjunction with the re-entrydevice to establish a blood flow path between around an occlusion in ablood vessel.

FIG. 21 is a partial cross-sectional view of an exemplary re-entrydevice.

FIG. 22 is a plan view of an exemplary re-entry device.

FIG. 23 is a partial cross-sectional view of an exemplary re-entrydevice.

FIG. 24 is a partial cross-sectional view of an exemplary re-entrydevice.

FIG. 25 is a plan view of an exemplary re-entry device.

FIG. 26 is a cross-sectional view of an exemplary re-entry device.

FIG. 27 is a cross-sectional view of an exemplary re-entry device.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

FIG. 1 is a somewhat stylized representation of a human heart 50. Heart50 includes a plurality of coronary arteries 52, all of which aresusceptible to occlusion. Under certain physiological circumstances andgiven sufficient time, some occlusions may become total or complete,such as total occlusion 36 shown in FIG. 1.

As used herein, the terms total occlusion and complete occlusion areintended to refer to the same or similar degree of occlusion with somepossible variation in the age of the occlusion. Generally, a totalocclusion refers to a vascular lumen that is ninety percent or morefunctionally occluded in cross-sectional area, rendering it with littleto no blood flow therethrough and making it difficult or impossible topass a conventional guide wire therethrough. Also generally, the olderthe total occlusion the more organized the occlusive material will beand the more fibrous and calcified it will become. According to oneaccepted clinical definition, a total occlusion is considered chronic ifit is greater than two weeks old from symptom onset.

FIG. 2 is an enlarged view further illustrating a portion of heart 50shown in the previous figure. In FIG. 2, a total occlusion 36 is shownwithin a coronary artery 52. Generally, the proximal segment 32 ofartery 52 (i.e., the portion of artery 52 proximal of total occlusion36) has adequate blood flow to supply the surrounding cardiac muscle andmay be easily accessed using endovascular devices. In contrast, thedistal segment 34 of artery 52 (i.e., the portion of artery 52 distal oftotal occlusion 36) is not easily accessed with interventional devices.Additionally, distal segment 34 has significantly reduced blood flow ascompared to proximal segment 32.

FIG. 3 is a perspective view of an artery 20 having a wall 22. In FIG.3, wall 22 of artery 20 is shown having three layers. The outermostlayer of wall 22 is the adventitia 24 and the innermost layer of wall 22is the intima 26. Intima 26 defines a true lumen 30 of artery 20. Thetissues extending between intima 26 and adventitia 24 may becollectively referred to as the media 28. For purposes of illustration,intima 26, media 28 and adventitia 24 are each shown as a singlehomogenous layer in FIG. 3. In the human body, however, the intima andthe media each comprise a number of sub-layers. The transition betweenthe external most portion of the intima and the internal most portion ofthe media is sometimes referred to as the subintimal space 40.

With reference to FIG. 3, it will be appreciated that the subintimalspace 40 has a generally annular shape with its radial center at thecenter of the true lumen. Some of the devices and methods discussed inthis detailed description may take advantage of the position andgeometry of the subintimal space 40 relative to the true lumen of theblood vessel. For example, some orienting devices described herein maybe adapted to orient themselves within that space. Once the orientationof the orienting device is established, the orienting device may be usedto direct a re-entry device toward the true lumen.

FIG. 4 is a lateral cross-sectional view of artery 20 shown in theprevious figure. In FIG. 4, an orienting device 100 is shown disposedbetween adventitia 24 and intima 26 of artery 20. Orienting device 100comprises a distal shaft 102 having an outer wall 128 defining a centrallumen 104. Orienting device 100 comprises an orienting element 120 thatis coupled to distal shaft 102.

In the embodiment of FIG. 4, orienting element 120 comprises aninflatable member 126. The top of inflatable member 126 may be fixed todistal shaft 102, for example, at a first interface 190A. The bottom ofinflatable member 126 may be fixed to distal shaft 102, for example, ata second interface 190B.

Orienting element 120 comprises a first portion 106 and a second portion108. First portion 106 of orienting element 120 extends in a firstdirection away from distal shaft 102. Second portion 108 of orientingelement 120 extends away from distal shaft 102 in a second directionthat is generally opposite the first direction.

Distal shaft 102 defines a first aperture 130 and a second aperture 132.First aperture 130 extends in a third direction through distal shaft102. Second aperture 132 extends through distal shaft 102 in a forthdirection that is generally opposite the third direction. First aperture130 and second aperture 132 are generally oriented at a right angle to atangent plane TP. In FIG. 4, tangent plane TP is tangent to subintimalspace 40.

When inflatable member 126 is inflated, the number of directions thatfirst aperture 130 and second aperture 132 may be facing is reduced.This may be conceptualized in terms of degrees of freedom. Wheninflatable member 126 of orienting element 120 is inflated, the numberof directions that an aperture may be facing is reduced from 360 degreesof freedom to two degrees of freedom, 180 degrees apart.

When inflatable member 126 of orienting element 120 is inflated betweenadventitia 24 and intima 26 of artery 20 orienting device 100 willorient itself within artery 20 so that either first aperture 130 orsecond aperture 132 opens toward a true lumen 30 of artery 20. In theembodiment of FIG. 4, orienting device 100 has been positioned so thatfirst aperture 130 opens toward intima 26 of artery 20 and secondaperture 132 opens toward adventitia 24. In FIG. 4, a re-entry device180 is shown extending through first aperture 130 and intima 26. Adistal end of re-entry device 180 is disposed in true lumen 30 of bloodvessel 20. Orienting device 100 and re-entry device 180 may be used toestablish fluid communication between a proximal segment and a distalsegment that are separated by an occlusion. Exemplary methods forestablishing this fluid communication will be described below.

FIG. 5 is a longitudinal cross-sectional view of an artery 20 having anocclusion 36 blocking true lumen 30 thereof. Occlusion 36 divides truelumen 30 into a proximal segment 32 and a distal segment 34. In FIG. 5,a distal portion of a guidewire 60 is shown extending into proximalsegment 32 of true lumen 30. The methods described in this document mayinclude the step of advancing a guidewire to a location proximate anocclusion in a blood vessel. The exemplary methods described in thisdocument may also include the step of advancing guidewire 60 betweenocclusion 36 and adventitia 24 of wall 22. In some cases, however, thenature of the occlusion and the blood vessel will be such that theguidewire is unlikely to advance beyond the occlusion. When this is thecase, the guidewire may be used to guide additional endovascular devicesto a location proximate occlusion 36.

FIG. 6 is an additional cross-sectional view of artery 20 shown in theprevious figure. In the embodiment of FIG. 6, a crossing device 70 hasbeen advanced over guidewire 60 so that a distal portion of crossingdevice 70 is disposed in proximal segment 32 of true lumen 30. Crossingdevice 70 of FIG. 6 comprises a tip 74 that is fixed to a distal end ofa shaft 72. Crossing device 70 may be used in conjunction with a methodfor establishing a channel between proximal segment 32 and distalsegment 34. The methods described in this document may include the stepof advancing a crossing device over a guidewire.

In some useful methods in accordance with the present disclosure,crossing device 70 may be rotated about it's longitudinal axis and movedin a direction parallel to it's longitudinal axis simultaneously. Whenthis is the case, rotation of crossing device 70 may reduce resistanceto the axial advancement of crossing device 70. These methods takeadvantage of the fact that the kinetic coefficient of friction isusually less than the static coefficient of friction for a givenfrictional interface. Rotating crossing device 70 assures that thecoefficient of friction at the interface between the crossing device andthe surround tissue will be a kinetic coefficient of friction and not astatic coefficient of friction.

FIG. 7 is a plan view showing an assembly including crossing device 70shown in the previous figure. In the embodiment of FIG. 7, a handleassembly 76 is coupled to crossing device 70. In FIG. 7, handle assembly76 is shown disposed about a proximal portion of a shaft 152 of crossingdevice 70. In FIG. 7, a portion of handle assembly 76 is positionedbetween the thumb and forefinger of a left hand LH. A second portion ofhandle assembly 76 is disposed between the thumb and forefinger of aright hand RH. With reference to FIG. 7, it will be appreciated thathandle assembly 76 is long enough to receive the thumb and forefingersof a physician's right and left hands. When this is the case, aphysician can use two hands to rotate handle assembly 76.

Rotation of crossing device 70 can be achieved by rolling handleassembly 76 between the thumb and forefinger of one hand. Two hands mayalso be used to rotate handle assembly 76 as shown in FIG. 7. In someuseful methods, crossing device 70 can be rotated and axially advancedsimultaneously.

In some useful methods in accordance with the present disclosure,crossing device 70 is rotated at a rotational speed of between about 2revolutions per minute and about 200 revolutions per minute. In someparticularly useful methods in accordance with the present disclosure,crossing device 70 is rotated at a rotational speed of between about 50revolutions per minute and about 150 revolutions per minute.

Crossing device 70 may be rotated by hand as depicted in FIG. 7. It isalso contemplated that a mechanical device (e.g., an electric motor) maybe used to rotate crossing device 70. Rotating crossing device 70assures that the coefficient of friction at the interface between thecrossing device and the surround tissue will be a kinetic coefficient offriction and not a static coefficient of friction.

FIG. 8 is an additional longitudinal cross-sectional view of artery 20.In the embodiment of FIG. 8, the distal end of crossing device 70 hasbeen advanced in a distal direction so that tip 74 is adjacent occlusion36. With reference to FIG. 8, it will be appreciated that tip 74 haspassed beyond intima 26 and is disposed between occlusion 36 andadventitia 24 of artery 20. Some methods described in this document mayinclude the step of advancing a crossing device between an occlusion andthe adventitia of an artery.

FIG. 9 is an additional view of artery 20 and crossing device 70 shownin the previous figure. In the embodiment of FIG. 9, the distal end ofcrossing device 70 has been advanced in an axial direction pastocclusion 36. Methods described herein may include the step of advancinga crossing device beyond an occlusion. In the embodiment of FIG. 9,crossing device has crossed occlusion 36 by advancing between occlusion36 and adventitia 24 of wall 22.

It is to be appreciated that other methods of crossing an occlusion arewithin the spirit and scope of this disclosure. For example, thecrossing device 70 may pass through occlusion 36 while remainingdisposed inside true lumen 30. In FIG. 9, tip 74 of crossing device 70is shown residing between intima 26 and adventitia 24 of artery 20. Astip 74 moves in an axial direction between intima 26 and adventitia 24,tip 74 may cause blunt dissection of the layers forming wall 22 ofartery 20. Alternatively, tip 74 may cause blunt dissection of thematerials comprising the occlusion 36.

In the embodiment of FIG. 9, tip 74 of crossing device 70 is disposedbetween intima 26 and adventitia 24. When this is the case, fluidcommunication between proximal segment 32 and distal segment 34 may beachieved by creating an opening through intima 26. Such an opening maybe created, for example, using a re-entry device and an orienting devicethat directs the advancement of the re-entry device toward intima 26.

FIG. 10 is an additional view of artery 20 shown in the previous figure.In the embodiment of FIG. 10, crossing device 70 has been withdrawn fromtrue lumen 30 of artery 20. With reference to FIG. 10, it will beappreciated that guidewire 60 remains in the position formerly occupiedby crossing device 70.

The position of guidewire 60 shown in FIG. 10 may be achieved usingcrossing device 70. Guidewire 60 may be positioned, for example, byfirst placing crossing device 70 in the position shown in the previousfigure, then advancing guidewire 60 through lumen 122 defined by shaft72 of crossing device 70. Alternately, guidewire 60 may be disposedwithin lumen 122 while crossing device 70 is advanced beyond occlusion36.

With guidewire 60 in the position shown in FIG. 10, guidewire 60 may beused to direct other devices between occlusion 36 and adventitia 24. Forexample, a catheter may be advanced over guidewire 60 until the distalend of the catheter extends between an occlusion and the adventia. Afterreaching this location, the catheter may be used to dilate the tissuesurrounding the catheter. Examples of catheters that may be used todilate tissue include balloon angioplasty catheters, atherectomycatheters, and stent delivery catheters.

FIG. 11 is an additional view of artery 20 and guidewire 60 shown in theprevious figure. In the embodiment of FIG. 11, an orienting device 100has been advanced over guidewire 60. Orienting device 100 includes adistal shaft 102 comprising a outer wall 128 defining a central lumen104. A first aperture 130 and a second aperture 132 are also defined byouter wall 128. In the embodiment of FIG. 11, first aperture 130 andsecond aperture 132 are both in fluid communication with central lumen104.

In the embodiment of FIG. 11, orienting device 100 has been positionedso that first aperture 130 opens toward intima 26 of artery 20 andsecond aperture 132 opens toward adventitia 24. In the embodiment ofFIG. 11, first aperture 130 and second aperture 132 are longitudinallyseparated from one another. Orienting device 100 includes a firstradiopaque marker that is located between first aperture 130 and secondaperture 132. A second radiopaque marker of orienting device 100 islocated distally of second aperture 132.

FIG. 12 is an additional view of artery 20 and orienting device 100shown in the previous figure. In the embodiment of FIG. 12, guidewire 60has been withdrawn leaving orienting device 100 in the position shown inFIG. 12. With reference to FIG. 12, it will be appreciated thatorienting device 100 extends beyond occlusion 36. In FIG. 12, occlusion36 is shown blocking true lumen 30. Occlusion 36 divides true lumen 30into a proximal segment 32 and a distal segment 34. When an orientingdevice in accordance with some embodiments disclosed herein is advancedbetween the adventitia and the intima of an artery, the orienting devicemay be used to direct a re-entry device toward true lumen 30. Fluidcommunication between proximal segment 32 and distal segment 34 may beachieved by re-entering the true lumen with a re-entry device.

FIG. 13 is an enlarged partial cross-sectional view showing a portion oforienting device 100 shown in the previous figure. In the embodiment ofFIG. 13, a re-entry device 180 has been advanced into central lumen 104of orienting device 100. With reference to FIG. 13, it will beappreciated that re-entry device 180 includes a bend 134 near distal end136 of re-entry device 180.

FIG. 14 is an additional partial cross-sectional view showing a portionof re-entry device 180 and orienting device 100. For purposes ofillustration, FIG. 14 is enlarged and simplified relative to the itemsshown in the previous figure. In the embodiment of FIG. 14, re-entrydevice 180 is biased to assume a bent shape including a bend 134. Alsoin the embodiment of FIG. 14, distal shaft 102 of orienting device 100is holding re-entry device 180 in a somewhat compressed state. When thisis the case, re-entry device 180 can be inserted through first aperture130 by positioning distal end 136 over first aperture 130 and allowingbend 134 to assume it's natural state (i.e., bent at a sharper angle).Re-entry device 180 can be inserted through first aperture 130 until itcomes into contact with intima 26.

It the embodiment of FIG. 14, distal end 136 of re-entry device 180 isaxially aligned with first aperture 130, however, bend 134 is causingdistal end 136 to point away from first aperture 130. When this is thecase, distal end 136 may be positioned over first aperture 130 byrotating re-entry device 180 central lumen 104 of orienting device 100.

FIG. 15 is an enlarged partial cross-sectional view showing a portion ofre-entry device 180 and orienting device 100 shown in the previousfigure. In the embodiment of FIG. 15, re-entry device 180 has beenpositioned so that a distal portion of reentry device 180 has enteredfirst aperture 130. Intima 26 is shown below first aperture 130 in FIG.15.

FIG. 16 is an enlarged partial cross-sectional view showing a portion ofre-entry device 180 and intima 26. In FIG. 16, re-entry device 180 isshown extending through central lumen 104 and first aperture 130. Withreference to FIG. 16, it will be appreciated that re-entry device 180comprises a distal surface 144 and a probe 146 extending beyond distalsurface 144. In the embodiment of FIG. 16, probe 146 of re-entry device180 is contacting intima 26.

FIG. 17 is an enlarged partial cross-sectional view showing a portion ofre-entry device 180. In the embodiment of FIG. 17, probe 146 of re-entrydevice 180 has pierced intima 26. When this is the case, probe 146 mayanchor the distal tip of re-entry device 180 to intima 26. Additionally,the piercing of intima 26 with probe 146 may serve to weaken intima 26.

FIG. 18 is an enlarged partial cross-sectional view showing a portion ofre-entry device 180. In the embodiment of FIG. 18, the distal end 136 ofre-entry device 180 has been advanced through intima 26. With referenceto FIG. 18, it will be appreciated that distal end 136 of re-entrydevice 180 is disposed in true lumen 30 defined by intima 26.

FIG. 19 is a partial cross-sectional view of re-entry device 180 shownin the previous figure. FIG. 19 has a different scale than the previousfigure so that more of the surrounding context is visible in FIG. 19. InFIG. 19, distal end 136 of re-entry device 180 can be seen residing intrue lumen 30.

FIG. 20 is an additional view of artery 20 shown in the previous figure.In the embodiment of FIG. 20, orienting device 100 has been withdrawnleaving re-entry device 180 in the position shown in FIG. 20. Devicessuch as balloon angioplasty catheters, atherectomy catheters, and stentdelivery catheters may be advanced over re-entry device 180. In thisway, these devices may be used in conjunction with re-entry device 180to establish a blood flow path between proximal segment 32 of true lumen30 and distal segment 34 of true lumen 30. This path allows blood toflow around occlusion 36.

FIG. 21 is a partial cross-sectional view of an exemplary re-entrydevice 280 in accordance with the present detailed description. Re-entrydevice 280 comprises a tip member 242 that is fixed to a shaft 240 and acoil 248 that is disposed about a distal portion of the shaft 240. Shaft240 comprises a proximal segment 250 that extends between a proximal endPE and a first tapered segment 252. In the embodiment of FIG. 21, coil248 extends between first tapered segment 252 and tip member 242.

A first intermediate segment 262 of shaft 240 extends between firsttapered segment 252 and a second tapered segment 254. A secondintermediate segment 264 of shaft 240 extends between second taperedsegment 254 and a third tapered segment 256. A distal segment 260 ofshaft 240 extends between third tapered segment 256 and tip member 242.With reference to FIG. 21, it will be appreciated that tip member 242 isfixed to distal segment 260 of shaft 240. In the embodiment of FIG. 21,a probe 246 of re-entry device 280 extends distally beyond a distalsurface 244 of tip member 242.

FIG. 22 is a plan view of an exemplary re-entry device 380 in accordancewith the present detailed description. Re-entry device 380 comprises atip member 342 having a distal surface 344. In the embodiment of FIG.22, distal surface 344 of tip member has a generally convex shape. Insome cases, tip member 342 may have a generally hemispherical shape. Aprobe 346 of re-entry device 380 extends distally beyond distal surface344. Probe 346 terminates at a distal face 358. In FIG. 22, distal face358 is shown as a straight line representing a substantially flatsurface. With reference to FIG. 22, it will be appreciated that distalface 358 is substantially perpendicular to the longitudinal axis ofprobe 346.

A number of exemplary dimensions associated with probe 346 areillustrated in FIG. 22. In the embodiment of FIG. 22, probe 346 extendsbeyond distal surface 344 of tip member 342 by a distance L. Also in theembodiment of FIG. 22, probe 346 has a diameter DA and tip member 342has a diameter DB. With reference to FIG. 22, it will be appreciatedthat diameter DB of tip member 342 is generally greater than diameter DAof probe 346.

In some useful embodiments, diameter DA of probe 346 is between about0.0020 inches and about 0.0055 inches. In some useful embodiments,diameter DB of tip member 342 is between about 0.008 inches and about0.035 inches. In some useful embodiments, length L of probe 346 isbetween about 0.003 inches and about 0.032 inches. In FIG. 22, a coil348 is shown extending between tip member 342 and a first taperedsegment 352. Shaft 340 comprises a proximal segment 350 that extendsbetween a proximal end PE and a first tapered segment 352.

FIG. 23 is a partial cross-sectional view of an exemplary re-entrydevice 480 in accordance with the present detailed description. Re-entrydevice 480 comprises a tip member 442 that is fixed to a distal segment460 of a shaft 440. In the embodiment of FIG. 23, tip member 442comprises a distal surface 444 and a probe 446 extending distally beyonddistal surface 444. In the embodiment of FIG. 23, distal surface 444 oftip member has a generally hemispherical shape and probe 446 has agenerally cylindrical shape terminating at a flat distal face 458. Withreference to FIG. 23, it will be appreciated that distal face 458 issubstantially perpendicular to the longitudinal axis of probe 446.

Various processes may be used to fabricate a tip member having a shapesimilar to tip member 442 shown in FIG. 23. A tip member may be formed,for example, using various manufacturing processes such as, for example,casting and molding. A tip member may also be fabricated by amanufacturing process comprising removing material from a piece of stockmaterial to produce a desired profile. Examples of processes that may beused to remove material from a piece of stock material include grindingand machining (e.g., turning on a lathe).

In the embodiment of FIG. 23, probe 446 extends beyond distal surface444 of tip member 442 by a distance L. Also in the embodiment of FIG.23, probe 446 has a diameter DA and tip member 442 has a diameter DB. Insome useful embodiments, the these dimensions fall with the numericalranges mentioned in the detailed description of FIG. 22.

FIG. 24 is a partial cross-sectional view of an exemplary re-entrydevice 580 in accordance with the present detailed description. Re-entrydevice 580 comprises a shaft 540 and a tip member 542 that is fixed to adistal segment 560 of shaft 540. A probe 546 of re-entry device 580extends distally beyond a distal surface 544 of tip member 542. In theembodiment of FIG. 24, probe 546 comprises a portion of distal segment560 that extends beyond distal surface 544. A coil 548 of re-entrydevice 580 extends between tip member 542 and a first tapered segment552 of shaft 540. Coil 548 is fixed to first tapered section 552 at ajoint 566. Joint 566 and tip member 542 may comprise, for example,silver (e.g., silver solder and/or silver braze). Joint 566 and tipmember 542 may be formed using various manufacturing processes (e.g.,soldering, brazing, and welding).

In the embodiment of FIG. 24, distal segment 560 of shaft 540 terminatesat a substantially flat distal face 558. Probe 546 comprises a portionof distal segment 560 that extends beyond distal surface 544 of tipmember 542 by a distance L. Also in the embodiment of FIG. 24, probe 546has a diameter DA and tip member 542 has a diameter DB. In some usefulembodiments, the these dimensions fall with the numerical rangesmentioned in the detailed description of FIG. 22.

FIG. 25 is a plan view of an exemplary re-entry device 680 in accordancewith the present detailed description. Re-entry device 680 comprises atip member 642 having a distal surface 644. In the embodiment of FIG.25, distal surface 644 of tip member has a generally convex shape. Insome cases, tip member 642 may have a generally hemispherical shape. Aprobe 646 of re-entry device 680 extends distally beyond distal surface644. Probe 646 terminates at a distal face 658. In FIG. 25, distal face658 is shown as a straight line representing a substantially flatsurface.

In FIG. 25, re-entry device 600 is shown being bent at an angle A.Accordingly, it can be said that re-entry device 600 includes a bend630. In some useful embodiments of re-entry device 600, angle A isbetween about 90 degrees and about 180 degrees. In some particularlyuseful embodiments of re-entry device 600, angle A is between about 120degrees and about 150 degrees. Re-entry device 680 has a distal leg 668disposed distally of bend 634 and a proximal leg 670 disposed proximallyof bend 634.

FIG. 26 is a cross-sectional view of an exemplary re-entry device 780 inaccordance with the present detailed description. Re-entry device 780comprises a core wire 772 and a jacket 774 that is disposed about aportion of core wire 772. Jacket 774 terminates at a distal surface 744.A probe 746 of re-entry device 780 extends distally beyond distalsurface 744. In the embodiment of FIG. 26, probe 746 comprises a distalsegment 760 of core wire 772.

FIG. 27 is a cross-sectional view of an exemplary re-entry device 780 inaccordance with the present detailed description. Re-entry device 780comprises a core wire 772 and a jacket 774 that is disposed about aportion of core wire 772. With reference to FIG. 27, it will beappreciated that re-entry device 780 includes a bend 734 near its distalend. Re-entry device 780 has a distal leg 768 disposed distally of bend734 and a proximal leg 770 disposed proximally of bend 734. Distal leg768 and proximal leg 770 define an angle A. In some useful embodimentsof re-entry device 700, angle A is between about 90 degrees and about180 degrees. In some particularly useful embodiments of re-entry device700, angle A is between about 120 degrees and about 150 degrees. Jacket774 of re-entry device 780 terminates at a distal surface 744. A probe746 of re-entry device 780 extends distally beyond distal surface 744.In the embodiment of FIG. 27, probe 746 comprises a distal segment 760of core wire 772.

From the foregoing, it will be apparent to those skilled in the art thatthe present invention provides, in exemplary non-limiting embodiments,devices and methods for the treatment of chronic total occlusions.Further, those skilled in the art will recognize that the presentinvention may be manifested in a variety of forms other than thespecific embodiments described and contemplated herein. Accordingly,departures in form and detail may be made without departing from thescope and spirit of the present invention as described in the appendedclaims.

1. A device, comprising: a shaft; a coil attached to the shaft; a tipmember distal to the coil and having a generally hemispherical shape;and a probe extending beyond a distal surface of the tip member and thecoil, wherein the probe includes a generally flat distal surface and isadapted and configured to pierce an intimal layer of a blood vessel. 2.The device of claim 1, wherein the probe extends beyond the tip memberby a distance that is greater than about 0.003 inches and less thanabout 0.012 inches.
 3. The device of claim 2, wherein the probe extendsbeyond the tip member by a distance that is greater than about 0.004inches and less than about 0.008 inches.
 4. The device of claim 1,wherein the probe has a diameter that is greater than about 0.002 inchesand less than about 0.006 inches.
 5. The device of claim 1, wherein theprobe has an aspect ratio of length to diameter that is greater thanabout
 1. 6. The device of claim 5, wherein the probe has an aspect ratioof length to diameter that is greater than about
 2. 7. The device ofclaim 1, wherein: the probe of the shaft has a maximum diameter DW; thetip member has a maximum diameter DT; and the maximum diameter DT isgreater than the maximum diameter DW of the probe.
 8. The device ofclaim 7, wherein a ratio of the maximum diameter DT of the tip member tothe maximum diameter DW of the probe is greater than about
 3. 9. Thedevice of claim 1, wherein the shaft comprises a proximal leg, a distalleg, and a bend disposed between the proximal leg and a distal leg. 10.The device of claim 9, wherein the bend extends through an angular rangethat is greater than about 90 degrees and less than about 180 degrees.11. The device of claim 10, wherein the bend extends through an angularrange that is greater than about 120 degrees and less than about 150degrees.
 12. The device of claim 9, wherein the distal leg has a lengththat is greater than about 0.040 inches and less than about 0.300inches.
 13. The device of claim 1, wherein a proximal end of the coil isfixed to the shaft and a distal end of the coil is fixed to the tipmember.
 14. The device of claim 1, wherein the tip member comprises ametal.
 15. The device of claim 14, wherein the metal comprises silver.16. The device of claim 1, wherein the probe comprises a distal portionof the shaft extending beyond a distal surface of the tip member. 17.The device of claim 16, wherein the distal surface of the tip memberextends between the coil and the probe.
 18. The device of claim 16,wherein the distal surface of the tip member extends between an outerextent of the coil and the probe.
 19. The device of claim 16, whereinthe tip member is fixed to both the coil and the shaft, and the tipmember extends between the coil and the shaft.
 20. The device of claim1, wherein the generally flat distal surface intersects a second surfaceof the probe at a sharp edge.
 21. A device, comprising: a shaft; a tipmember fixed to the shaft having a generally hemispherical shape, thetip member being a discrete component from the shaft; a coil having aproximal end attached to the shaft and a distalmost end directlyattached to the tip member; and wherein a distal portion of the shaftextends beyond a distal surface of the tip member, wherein a distalsurface of the distal portion of the shaft is a distalmost surface ofthe device, wherein the distalmost surface is substantially flat and isadapted and configured to pierce an intimal layer of a blood vessel. 22.The device of claim 21, wherein the distal portion of the shaft extendsbeyond the tip member by a distance that is greater than about 0.003inches and less than about 0.012 inches.
 23. The device of claim 22,wherein the distal portion of the shaft extends beyond the tip member bya distance that is greater than about 0.004 inches and less than about0.008 inches.
 24. The device of claim 21, wherein the distal portion ofthe shaft has a diameter that is greater than about 0.002 inches andless than about 0.006 inches.
 25. The device of claim 21, wherein thedistal portion of the shaft has an aspect ratio of length to diameterthat is greater than about
 1. 26. The device of claim 21, wherein thedistal portion of the shaft has an aspect ratio of length to diameterthat is greater than about
 2. 27. The device of claim 21, wherein: thedistal portion of the shaft has a maximum diameter DW; the tip memberhas a maximum diameter DT; and the maximum diameter DT is greater thanthe maximum diameter DW of the distal portion of the shaft.
 28. Thedevice of claim 21, wherein a diameter of the coil is substantially thesame as a diameter of a proximal end of the tip member.
 29. A device,comprising: a shaft; a tip member fixed to the shaft, the tip memberbeing a discrete component from the shaft; a coil having a distalmostend directly attached to the tip member; and wherein a distal portion ofthe shaft extends beyond a distal surface of the tip member, and adistal surface of the distal portion of the shaft is a distalmostsurface of the device, wherein the distalmost surface is substantiallyflat and is adapted and configured to pierce an intimal layer of a bloodvessel.
 30. The device of claim 29, wherein: the distal portion of theshaft has a maximum diameter DW; the tip member has a maximum diameterDT; and the maximum diameter DT is greater than the maximum diameter DWof the distal portion of the shaft.
 31. The device of claim 29, whereina proximal end of the coil is attached to the shaft.
 32. The device ofclaim 29, wherein a diameter of the coil is substantially the same as adiameter of a proximal end of the tip member.
 33. The device of claim29, wherein the distalmost surface of the distal portion of the shaft issubstantially transverse to a longitudinal axis of the shaft.
 34. Thedevice of claim 33, wherein the distal portion of the shaft has agenerally rectangular cross-section along a longitudinal axis of theshaft.
 35. The device of claim 29, wherein a diameter of the distalportion of the shaft is less than half of a diameter of the tip member.36. The device of claim 29, wherein the distal portion of the shaftincludes at least one sharp edge.
 37. A device, comprising: a shaft; atip member fixed to the shaft, the tip member being a discrete componentfrom the shaft; and a coil having a distal end attached to the tipmember; wherein a distal portion of the shaft extends beyond a distalsurface of the tip member and the coil, and a distal surface of thedistal portion of the shaft is a distalmost surface of the device,wherein the distalmost surface is substantially flat and is configuredand adapted to pierce an intimal layer of a blood vessel wall.
 38. Thedevice of claim 37, wherein: the distal portion of the shaft has amaximum diameter DW; the tip member has a maximum diameter DT; and themaximum diameter DT is greater than the maximum diameter OW of thedistal portion of the shaft.
 39. The device of claim 37, wherein aproximal end of the coil is attached to the shaft.
 40. The device ofclaim 37, wherein a diameter of the coil is substantially the same as adiameter of a proximal end of the tip member.
 41. The device of claim37, wherein the distalmost surface of the distal portion of the shaft issubstantially transverse to a longitudinal axis of the shaft.
 42. Thedevice of claim 41, wherein the distal portion of the shaft has agenerally rectangular cross-section along the longitudinal axis.
 43. Thedevice of claim 37, wherein a diameter of the distal portion of theshaft is less than half of a diameter of the tip.
 44. The device ofclaim 37, wherein the tip member has a generally convex shape.
 45. Thedevice of claim 37, wherein the distalmost surface forms at least onesharp edge.